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Major asthma guideline update: ICS-LABA as-needed replaces albuterol
In their first major update in 30 years, newly published asthma guidelines recommend significant changes to the way physicians treat millions of patients diagnosed with asthma.
The Global Initiative for Asthma (GINA) now advises that, in general:
Most people with asthma can now be prescribed just one inhaler: an inhaled corticosteroid-and-long-acting beta agonist (ICS-LABA) combination product, to be used as both a maintenance (preventive) and rescue inhaler.
Starting with a ICS-LABA is suggested for almost all patients, even those with mild asthma. Before, the recommendation was to start with ICS alone and "step up" to ICS-LABA, if the benefits outweighed the supposed risks.
All patients diagnosed with asthma should be prescribed at minimum an inhaled corticosteroid (as-needed albuterol as monotherapy is discouraged). Previously, patients with mild intermittent asthma (symptoms twice a week or less, and nighttime symptoms less than monthly) were advised to take albuterol as-needed, without a steroid inhaler for prevention.
For patients with mild intermittent symptoms, the ICS-LABA should include low-dose ICS and should be used as-needed for asthma symptoms. During periods of good asthma control, patients can go without any inhalers. The ICS-LABA inhaler replaces albuterol as a rescue inhaler.
For patients with moderate or severe asthma, the ICS-LABA may be used as both maintenance (daily) preventive treatment, and also as a rescue inhaler, with extra inhalations taken for breakthrough asthma symptoms as needed. Higher-dose ICS may be required in patients with more severe asthma.
Albuterol inhalers may be avoided entirely for many patients with asthma, although GINA does not advise against their use as an add-on reliever therapy.
GINA recommends budesonide or beclomethasone as the inhaled corticosteroid in the ICS-LABA, and formoterol as the long-acting beta agonist. There is only one such combination product in the U.S., sold as Symbicort (budesonide-formoterol). Fostair is a beclomethasone-formoterol product sold outside the U.S.
The new guidelines make asthma treatment much simpler for the majority of patients living with asthma. Implementation would require adjustment by insurers and pharmacists, whose current operations may block patients from filling their ICS-LABA prescriptions “early” during periods of poor asthma control with associated increased use. Neither Symbicort (budesonide-formoterol), Foradil (formoterol), nor Qvar (beclomethasone) currently has an FDA indication for as-needed use, so all such prescribing and use would be off-label.
The recommendations endorse only the use of formoterol as a LABA, not salmeterol, the LABA present in Advair and its generic (Wixela Inhub), which are dry powder inhalers that are not well suited for as-needed use in the GINA guidelines. In the U.S., the guidelines are effectively a recommendation for Symbicort.
GINA made this major update -- the first of its kind in decades -- in response mainly to a randomized trial showing the effectiveness of ICS-LABA as a single inhaler strategy, which has been standard therapy in Europe for many years. After concerns about LABA adverse effects in the mid-2000s, multiple large trials eventually demonstrated the safety of ICS-LABA products in the treatment of asthma.
The irony is that for decades, doctors have been scolding asthma patients for “noncompliance” for naughty behaviors like stopping use of their controller inhalers during periods of good asthma control, or for “over-using” them during periods of increased symptoms. It turns out those patients were on to something, and the evidence and guidelines finally caught up with them.